Methods and apparatus for processing fluids

ABSTRACT

A method for processing a fluid includes removably securing a retention member to a vessel that bounds a chamber; inserting a collapsible bag within the chamber of the vessel; securing the bag to the retention member so that the bag is supported within the chamber of the vessel; and dispensing a fluid into a compartment of the collapsible bag supported within the chamber of the vessel. The fluid can be mixed within bag while the bag is disposed within the vessel.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/878,299, filed Oct. 8, 2015, which is a continuation of U.S.application Ser. No. 12/986,701, filed Jan. 7, 2011, now U.S. Pat. No.9,314,751, which are incorporated herein by specific reference.

BACKGROUND OF THE INVENTION 1. The Field of the Invention

The present invention relates to methods and systems for processingfluids, namely, biological fluids.

2. The Relevant Technology

The biopharmaceutical industry uses a broad range of mixing systems fora variety of processes such as in the preparation of media and buffersand in the growing of cells and microorganisms in bioreactors. Manyconventional mixing systems, including bioreactors, comprise a rigidtank that can be sealed closed. A drive shaft with impeller is rotatablydisposed within the tank. The impeller functions to suspend and mix thecomponents.

In many cases, great care must be taken to sterilize and maintain thesterility of the mixing system so that the culture or other product doesnot become contaminated. Accordingly, between the production ofdifferent batches, the mixing tank, mixer, and all other reusablecomponents that contact the processed material must be carefully cleanedto avoid any cross contamination. The cleaning of the structuralcomponents is labor intensive, time consuming, and costly. For example,the cleaning can require the use of chemical cleaners such as sodiumhydroxide and may require steam sterilization as well. The use ofchemical cleaners has the additional challenge of being relativelydangerous, and cleaning agents can be difficult and/or expensive todispose of once used.

Furthermore, biological fluids are often produced in bulk at amanufacturing facility and then shipped in smaller quantities tocustomers for further processing or utilization. This process typicallyentails manufacturing a fluid through use of a mixing process,dispending the fluid into a transport container, and then shipping thetransport container to a customer. The customer then dispenses the fluidinto a further processing container so that the fluid can be remixed orresuspended so that the fluid is homogeneous prior to use. As can beappreciated, this transferring of fluids between different containerscan be time consuming, labor intensive and run the risk of breachingsterility.

Accordingly, what is needed are mixing systems that require minimumcleaning or sterilization. What is also needed are systems that that canbe used for preparing, transporting, and resuspending solutions that aresimple to use and minimize in risk of breaching sterility.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present invention will now be discussed withreference to the appended drawings. It is appreciated that thesedrawings depict only typical embodiments of the invention and aretherefore not to be considered limiting of its scope.

FIG. 1 is a perspective view of a container station docked with adocking station;

FIG. 2 is a perspective view of a container assembly that is used withthe container station shown in FIG. 1 ;

FIG. 3 is an elevated side view of an impeller assembly forming part ofthe container assembly shown in FIG. 2 and a drive shaft;

FIG. 4 is a front perspective view of the container station shown inFIG. 1 ;

FIG. 5 is a perspective view of a door of the container station shown inFIG. 4 ;

FIG. 6 is a is a bottom perspective view of the container station shownin FIG. 4 ;

FIG. 7 is a front perspective view of the docking station shown in FIG.1 ;

FIG. 8 is a top perspective view of the locking assembly shown in FIG. 7;

FIG. 9 is a partially disassembly perspective view of a drive motorassembly of the docking station shown in FIG. 7 in association with theimpeller assembly and drive shaft;

FIG. 10 is a top perspective view of the docking station shown in FIG. 7;

FIG. 11 is an alternative perspective view of the docking station shownin FIG. 7 ;

FIG. 12 is a front perspective view of the drive motor assembly androtational assembly;

FIG. 13 is an elevated front view of the rotational assembly shown inFIG. 12 coupled with the drive motor assembly;

FIG. 14 is a perspective view of an alternative embodiment of acontainer being used with a drive motor assembly and impeller assembly;

FIG. 15 is a perspective view of an alternative embodiment of theimpeller assembly shown in FIG. 14 .

FIG. 16 is a perspective view of one embodiment of a mixing systemincorporating features of the present invention;

FIG. 17 is a perspective view of one embodiment of a container assemblythat can be used in the mixing system shown in FIG. 16 ;

FIG. 18 is a front perspective view of the container assembly shown inFIG. 16 ;

FIG. 19 is a top perspective view of the cart of the container assemblyshown in FIG. 18 ;

FIG. 20 is a partially exploded perspective view of the containerassembly shown in FIG. 18 ;

FIG. 21 is a cross sectional side view of the shipping vessel of thecontainer assembly shown in FIG. 18 ;

FIG. 22 is rear perspective view of the container assembly shown in FIG.18 ; and

FIG. 23 is front perspective view of the container assembly shown inFIG. 18 having a lid mounted thereon.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention relates to systems and methods for mixing and, ifdesired, sparging solutions and/or suspensions. The systems can becommonly used as bioreactors or fermenters for culturing cells ormicroorganisms. By way of example and not by limitation, the inventivesystems can be used in culturing bacteria, fungi, algae, plant cells,animal cells, protozoans, nematodes, and the like. The systems canaccommodate cells and microorganisms that are aerobic or anaerobic andare adherent or non-adherent. The systems can also be used inassociation with the formation and/or treatment of solutions and/orsuspensions that are for biological purposes, such as media, buffers, orreagents. For example, the systems can be used in the formation of mediawhere sparging is used to control the pH of the media through adjustmentof the carbonate/bicarbonate levels with controlled gaseous levels ofcarbon dioxide. The systems can also be used for mixing powders or othercomponents into a liquid where sparging is not required and/or where issolution is not for biological purposes. In addition, alternativeembodiments of the present invention can be used for initially mixingsolutions, such as the above, followed by shipping and then remixing orsuspending the solution once it has reached a desired destination.

The inventive systems are designed so that a majority of the systemcomponents that contact the material being processed can be disposed ofafter each use. As a result, the inventive systems substantiallyeliminate the burden of cleaning and sterilization required byconventional stainless steel mixing systems. This feature also ensuresthat sterility can be consistently maintained during repeated processingof multiple batches. The inventive systems are also adjustable so thatthey can be used for mixing a variety of different batch sizes. In viewof the foregoing, and the fact that the inventive systems are easilyscalable, relatively low cost, and easily operated, the inventivesystems can be used in a variety of industrial and research facilitiesthat previously outsourced such processing.

Depicted in FIG. 1 is one embodiment of an inventive system 10incorporating features of the present invention. In general, system 10comprises a docking station 12, a container station 14 that removablydocks with docketing station 12, a container assembly 16 (FIG. 2 ) thatis supported by container station 14, and a drive shaft 362 (FIG. 3 )that extends between docking station 12 and container assembly 16.Container assembly 16 houses the solution or suspension that is mixed.The various components of system 10 will now be discussed in greaterdetail.

As depicted in FIG. 2 , container assembly 16 comprises a container 18having a side 20 that extends from an upper end 22 to an opposing lowerend 24. Container 18 also has an interior surface 26 that bounds acompartment 28. Compartment 28 is configured to hold a fluid. In theembodiment depicted, container 18 comprises a flexible bag that iscomprised of a flexible, water impermeable material such as alow-density polyethylene or other polymeric sheets having a thickness ina range between about 0.1 mm to about 5 mm with about 0.2 mm to about 2mm being more common. Other thicknesses can also be used. The materialcan be comprised of a single ply material or can comprise two or morelayers which are either sealed together or separated to form a doublewall container. Where the layers are sealed together, the material cancomprise a laminated or extruded material. The laminated materialcomprises two or more separately formed layers that are subsequentlysecured together by an adhesive.

The extruded material comprises a single integral sheet that comprisestwo or more layers of different materials that can be separated by acontact layer. All of the layers are simultaneously co-extruded. Oneexample of an extruded material that can be used in the presentinvention is the HyQ CX3-9 film available from HyClone Laboratories,Inc. out of Logan, Utah. The HyQ CX3-9 film is a three-layer, 9 mil castfilm produced in a cGMP facility. The outer layer is a polyesterelastomer coextruded with an ultra-low density polyethylene productcontact layer. Another example of an extruded material that can be usedin the present invention is the HyQ CX5-14 cast film also available fromHyClone Laboratories, Inc. The HyQ CX5-14 cast film comprises apolyester elastomer outer layer, an ultra-low density polyethylenecontact layer, and an EVOH barrier layer disposed therebetween. In stillanother example, a multi-web film produced from three independent websof blown film can be used. The two inner webs are each a 4 mil monolayerpolyethylene film (which is referred to by HyClone as the HyQ BM1 film)while the outer barrier web is a 5.5 mil thick 6-layer coextrusion film(which is referred to by HyClone as the HyQ BX6 film).

The material is approved for direct contact with living cells and iscapable of maintaining a solution sterile. In such an embodiment, thematerial can also be sterilizable such as by ionizing radiation.Examples of materials that can be used in different situations aredisclosed in U.S. Pat. No. 6,083,587 which issued on Jul. 4, 2000 and USPublication No. US 2003-0077466 A1, published Apr. 24, 2003 which arehereby incorporated by specific reference.

In one embodiment, container 18 comprise a two-dimensional pillow stylebag wherein two sheets of material are placed in overlapping relationand the two sheets are bonded together at their peripheries to form theinternal compartment. Alternatively, a single sheet of material can befolded over and seamed around the periphery to form the internalcompartment. In another embodiment, the containers can be formed from acontinuous tubular extrusion of polymeric material that is cut to lengthand is seamed closed at the ends.

In still other embodiments, container 18 can comprise athree-dimensional bag that not only has an annular side wall but also atwo dimensional top end wall and a two dimensional bottom end wall.Three dimensional containers comprise a plurality of discrete panels,typically three or more, and more commonly four or six. Each panel issubstantially identical and comprises a portion of the side wall, topend wall, and bottom end wall of the container. Corresponding perimeteredges of each panel are seamed. The seams are typically formed usingmethods known in the art such as heat energies, RF energies, sonics, orother sealing energies.

In alternative embodiments, the panels can be formed in a variety ofdifferent patterns. Further disclosure with regard to one method ofmanufacturing three-dimensional bags is disclosed in US Publication No.US 2002-0131654 A1 that was published Sep. 19, 2002 of which thedrawings and Detailed Description are hereby incorporated by reference.

It is appreciated that container 18 can be manufactured to havevirtually any desired size, shape, and configuration. For example,container 18 can be formed having a compartment sized to 10 liters, 30liters, 100 liters, 250 liters, 500 liters, 750 liters, 1,000 liters,1,500 liters, 3,000 liters, 5,000 liters, 10,000 liters or other desiredvolumes. Although container 18 can be any shape, in one embodimentcontainer 18 is specifically configured to be complementary orsubstantially complementary to the chamber on container station 14 inwhich container 18 is received, as will be discussed below.

In any embodiment, however, it is desirable that when container 18 isreceived within the chamber on container station 14, container 18 is atleast generally uniformly supported by container station 14. Having atleast general uniform support of container 18 by container station 14helps to preclude failure of container 18 by hydraulic forces applied tocontainer 18 when filled with fluid.

Although in the above discussed embodiment container 18 has a flexible,bag-like configuration, in alternative embodiments it is appreciatedthat container 18 can comprise any form of collapsible container orsemi-rigid container. Container 18 can also be transparent or opaque andcan have ultraviolet light inhibitors incorporated therein.

Continuing with FIG. 2 , formed on container 18 are a plurality of ports30 at upper end 22 and a plurality of ports 31 and 32 on opposing sidesof side 20 at lower end 24. Each of ports 30-32 communicate withcompartment 28. Although only a few ports 30-32 are shown, it isappreciated that container 18 can be formed with any desired number ofports 30-32 and that ports 30-32 can be formed at any desired locationon container 18. Ports 30-32 can be the same configuration or differentconfigurations and can be used for a variety of different purposes. Forexample, ports 30 can be coupled with fluid lines for delivering media,cell cultures, and/or other components into container 18 and withdrawinggas from container 18. Ports 31 and/or 32 can be useful in withdrawingfluid from container 18 or can have other purposes.

Ports 30-32 can also be used for coupling probes to container 18. Forexample, when container 18 is used as a bioreactor for growing cells ormicroorganisms, ports 30-32 can be used for coupling probes such astemperatures probes, pH probes, dissolved oxygen probes, and the like.Examples of ports 30-32 and how various probes and lines can be coupledthereto is disclosed in US Publication No. 2006-0270036, published Nov.30, 2006 and US Publication No. 2006-0240546, published Oct. 26, 2006,which are incorporated herein by specific reference. Ports 30-32 canalso be used for coupling container 18 to secondary containers, tocondenser systems, and to other desired fittings.

As also shown in FIG. 2 , container assembly 16 can comprise a pluralityof radially spaced apart alignment tabs 38 projecting from lower end 24of container 18. In the embodiment depicted, each alignment tab 38comprises a single tab welded to container 18 and having a opening 39extending therethrough. In alternative embodiments, alignment tabs 38can comprise a loop of material that bound an opening passingtherethrough or can have other configurations that permit the tab toattach to a structure. As discussed below in greater detail, alignmenttabs 38 can be used for proper positing of container assembly 16 withincontainer station 14.

In one embodiment of the present invention, container assembly 16includes means for delivering a gas into the lower end of container 18.By way of example and not by limitation, container assembly 16 cancomprise a sparger 34 positioned either on or mounted to lower end 24 ofcontainer 18 for delivering a gas to the fluid within container 18. Asis understood by those skilled in the art, various gases are typicallyrequired in the growth of cells or microorganisms within container 18.The gas typically comprises air that is selectively combined withoxygen, carbon dioxide and/or nitrogen. However, other gases can also beused. The addition of these gases can be used to regulate the dissolvedoxygen content and pH of a culture. A gas line 36 is coupled withsparger 34 for delivering the desired gas to sparger 34. Gas line 36need not pass through lower end 24 of container 18 but can extend downfrom upper end 22 or from other locations.

Sparger 34 can have a variety of different configurations. For example,sparger 34 can comprise a permeable membrane or a fritted structurecomprised of metal, plastic or other materials that dispense the gas insmall bubbles into container 18. Smaller bubbles can permit betterabsorption of the gas into the fluid. In other embodiments, sparger 34can simply comprise a tube, port, or other type opening formed on orcoupled with container 18 through which gas is passed into container 18.In contrast to being disposed on container 18, the sparger can also beformed on or coupled with impeller 64 which is discussed below. Examplesof spargers and how they can be used in the present invention aredisclosed in US Publication Nos. 2006-0270036 and 2006-0240546 whichwere previously incorporated by reference. Other conventional spargerscan also be used.

Container assembly 16 further comprises an impeller assembly 40. Asdepicted in FIG. 3 , impeller assembly 40 comprises an elongated tubularconnector 44 having a rotational assembly 48 mounted at one end and animpeller 64 mounted on the opposing end. More specifically, tubularconnector 44 has a first end 46 and an opposing second end 48 with apassage 50 that extends therebetween. In one embodiment, tubularconnector 44 comprises a flexible tube such as a polymeric tube. Inother embodiments, tubular connector 44 can comprise a rigid tube orother tubular structure.

Rotational assembly 48 is mounted to first end 46 of tubular connector44. Rotational assembly 48 comprises an outer casing 50 having anoutwardly projecting flange 52 and a tubular hub 54 rotatably disposedwithin outer casing 50. A bearing assembly can be disposed between outercasing 50 and tubular hub 54 to permit free and easy rotation of hub 54relative to casing 50. Likewise, one or more seals can be formed betweenouter casing 50 and tubular hub 54 so that during use an aseptic sealcan be maintained between outer casing 50 and tubular hub 54 as tubularhub 54 rotates relative to outer casing 50.

Hub 54 has an interior surface 56 that bounds an opening 58 extendingtherethrough. As will be discussed below in greater detail, an engagingportion of interior surface 56 has a polygonal or other non-circulartransverse cross section so that a driver portion of drive shaft 362passing through opening 58 can engage the engaging portion andfacilitate rotation of hub 54 by rotation of drive shaft 362. Hub 54 canalso comprise a tubular stem 60 projecting away from outer casing 50.Hub 54 can couple with first end 44 of tubular connector 42 by stem 60being received within first end 44. A pull tie, clamp, crimp or otherfastener can then be used to further secure stem 60 to tubular connect42 so that a liquid tight seal is formed therebetween. Otherconventional connecting techniques can also be used.

Impeller 64 comprises a central hub 66 having a plurality of fins 68radially outwardly projecting therefrom. It is appreciated that avariety of different numbers and configurations of fins 68 can bemounted on hub 66. Hub 66 has a first end 70 with a blind socket 72formed thereat. Socket 72 typically has a noncircular transverse crosssection, such as polygonal, so that it can engage a driver portion ofdrive shaft 362. Accordingly, as will be discussed below in greaterdetail, when a driver portion is received within socket 72, the driverportion engages with impeller 64 such that rotation of drive shaft 362facilities rotation of impeller 64.

In one embodiment, hub 66 and fins 68 of impeller 64 are molded from apolymeric material. In alternative embodiments, hub and fins 68 can bemade of metal, composite, or a variety of other materials. If desired,an annular insert can be positioned within socket 72 to help reinforcehub 66. For example, the insert can be comprised of metal or othermaterial having a strength property greater than the material from whichhub 66 is comprised.

Impeller 64 can be attached to connector 42 by inserting first end 70 ofhub 66 within connector 42 at second end 46. A pull tie, clamp, crimp,or other type of fastener can then be cinched around second end 46 ofconnector 42 so as to form a liquid tight sealed engagement betweenimpeller 64 and connector 42.

Returning to FIG. 2 , rotational assembly 48 is secured to container 18so that tubular connector 42 and impeller 64 extend into or are disposedwithin compartment 28 of container 18. Specifically, in the depictedembodiment container 18 has an opening 74 at upper end 22. Flange 52 ofouter casing 50 is sealed around the perimeter edge bounding opening 74so that hub 54 is aligned with opening 74. Tubular connector 42 havingimpeller 64 mounted on the end thereof projects from hub 54 intocompartment 28 of container 18. In this configuration, outer casing 50is fixed to container 18 but hub 54, and thus also tubular connector 42and impeller 64, can freely rotate relative to outer casing 50 andcontainer 18. As a result of rotational assembly 48 sealing opening 74,compartment 28 is sealed closed so that it can be used in processingsterile fluids.

As depicted in FIG. 3 , impeller assembly 40 is used in conjunction withdrive shaft 362. In general drive shaft 362 comprises a head section 364and a shaft section 366 that can be coupled together by threadedconnection or other techniques. Alternatively, draft shaft 362 can beformed as a single piece member or from a plurality of attachablesections. Drive shaft 362 has a first end 368 and an opposing second end370. Formed at first end 368 is a frustoconical engaging portion 372that terminates at a circular plate 374. Notches 376 are formed on theperimeter edge of circular plate 374 and are used for engaging driveshaft 362 with a drive motor assembly as will be discussed below.

Formed at second end 370 of drive shaft 362 is a driver portion 378.Driver portion 378 has a non-circular transverse cross section so thatit can facilitate locking engagement within hub 66 of impeller 64. Inthe embodiment depicted, driver portion 378 has a polygonal transversecross section. However, other non-circular shapes can also be used. Adriver portion 380 is also formed along drive shaft 362 toward first end368. Driver portion 380 also has a non-circular transverse cross sectionand is positioned so that it can facilitate locking engagement withinthe interior surface of hub 54 of rotational assembly 48.

During use, as will be discussed below in further detail, drive shaft362 is advanced down through hub 54 of rotational assembly 48, throughtubular connecter 42 and into hub 66 of impeller 64. As a result of theinterlocking engagement of driver portions 378 and 380 with hubs 66 and54, respectively, rotation of drive shaft 362 by a drive motor assemblyfacilitates rotation of hub 54, tubular connecter 42 and impeller 64relative to outer casing 50 of rotational assembly 48. As a result ofthe rotation of impeller 64, fluid within container 18 is mixed.

It is appreciated that impeller assembly 40, drive shaft 362 and thediscrete components thereof can have a variety of differentconfiguration and can be made of a variety of different materials.Alternative embodiments of and further disclosure with respect toimpeller assembly 40, drive shaft 362, and the components thereof aredisclosed in US Patent Publication No. 2011/0188928, published Aug. 4,2011, which is incorporated herein in its entirety by specificreference.

Returning to FIG. 1 , container station 14 comprises a support housing78 supported on a cart 80. Support housing 78 has a substantiallycylindrical sidewall 82 that extends between an upper end 84 and anopposing lower end 86. Lower end 86 has a floor 88 (FIG. 6 ) mountedthereto. As a result, support housing 14 has an interior surface 90 thatbounds a chamber 92. An annular lip 94 is formed at upper end 84 andbounds an opening 96 to chamber 92. As discussed above, chamber 92 isconfigured to receive container assembly 16 so that container 18 issupported therein.

Although support housing 78 is shown as having a substantiallycylindrical configuration, in alternative embodiments support housing 78can have any desired shape capable of at least partially bounding acompartment. For example, sidewall 82 need not be cylindrical but canhave a variety of other transverse, cross sectional configurations suchas polygonal, elliptical, or irregular. Furthermore, it is appreciatedthat support housing 78 can be scaled to any desired size. For example,it is envisioned that support housing 78 can be sized so that chamber 92can hold a volume of less than 50 liters, more than 1,000 liters or anyof the other volumes as discussed above with regard to container 18.Support housing 78 is typically made of metal, such as stainless steel,but can also be made of other materials capable of withstanding theapplied loads of the present invention.

With continued reference to FIG. 1 , sidewall 82 of support housing 78has a first side face 100 and an opposing second side face 102. Anenlarged access 104 is formed on second side face 102 at lower end 86 soas to extend through sidewall 82. A door 106 is hingedly mounted tosidewall 82 and can selectively pivot to open and close access 104. Alatch assembly 108 is used to lock door 106 in the closed position. Anopening 110, which is depicted in the form of an elongated slot, extendsthrough door 106. Opening 110 is configured to align with ports 32 (FIG.2 ) of container assembly 16 when container station 14 is receivedwithin chamber 92 so that ports 32 project into or can otherwise beaccessed through opening 110. In some embodiments, a line for carryingfluid or gas will be couple with port 32 and can extend out of chamber29 through opening 110. As previously mentioned, any number of ports 32can be formed on container 18 and thus a number of separated lines maypass out through opening 110. Alternatively, different types of probes,inserts, connectors or the like may be coupled with ports 32 which canbe accessed through opening 110.

Turning to FIG. 4 , similar to second side face 102, an enlarged access114 is formed on first side face 100 at lower end 86 so as to extendthrough sidewall 82. A door 116 is hingedly mounted to sidewall 82 andcan selectively pivot to open and close access 114. A latch assembly 118is used to lock door 116 in the closed position. An opening 120, whichis depicted in the form of an elongated slot, extends through door 116.Opening 120 is configured to align with ports 32 (FIG. 2 ) of containerassembly 16 when container assembly 16 is received within chamber 92 andserves the same corresponding function as discussed above with regard toopening 110.

As shown in FIG. 1 , door 106 has an exterior surface 107 that issubstantially flush with the exterior surface of side wall 82 when door106 is in the closed position. In contrast, as shown in FIG. 5 , door116 has a perimeter frame 128 that includes a first side rail 129, aspaced part second side rail 130, an upper rail 131 that extends betweenthe upper ends of rails 129 and 130, and a lower rail 132 that extendsbetween the lower ends of rails 129 and 130. Each of rails 129-132 hasan inside face 134 that extends between an interior surface 136 and anexterior surface 138. Door 116 further includes a panel 140 having afront face 142 and an opposing back face 144. Panel 140 is mounted on oradjacent to inside face 134 of rails 129-132 so that back face 144 ofpanel 140 is disposed substantially flush with interior surface 80 ofsupport housing 78 when door 116 is in the closed position. Panel 140has opening 120 extending therethrough. As a result of the position ofpanel 140, a recess 146 is formed on door 116 that is bounded in part byfront face 142 of panel 140 and inside face 134 of rails 129-132.

An elongated rack 148 is connected to and extends between inside faces134 of side rails 129 and 130 so that rack 148 is retained within recess146. In the depicted embodiment rack 148 comprises a flat bar that iscurved along the length thereof. Alternatively, other support structurescan also be used. Rack 148 is positioned so as to be slightly above oraligned with opening 120. Rack 148 is disposed within recess 148 to helpprotect it from damage during movement, shipping or use of containerstation 14. In alternative embodiments, rack 148 can project outside ofrecess 146, can be mounted on exterior faces of rails 129 and 130 or canbe formed in a generally elongated U-shaped configuration and mounted onthe exterior surface of door 116.

Rack 148 is used to support one or more removable hose supports 150. Asshown in FIG. 5 , each hose support 150 comprises an elongated shaft 152having a first end 154 and an opposing second end 156. Mounted at firstend 154 is a conventional hose clamp 158. Hose clamp 158 comprises apair of resiliently flexible arms that can be manually pried apart. Oncethe hose is positioned between the arms, the arms resiliently press backtoward each other so as to secure the hose therebetween. Other hoseclamps or other structures capable of holding or securing a hose canalso be used. Downwardly projecting from second end 156 of shaft 152 isa pair of spaced apart rigid arms 160 and 161 that bound a slot 162therebetween. Hose support 150 is attached to rack 148 by sliding rack148 into slot 162. A set screw 164 can then be threaded through arm 160to bias against rack 148 so as to secure hose clamp 150 to rack 148.Other conventional mounting structures can also be used for removablysecuring hose support 150 to rack 148.

Hose clamps 150 are used for supporting hoses that extend out of opening120 and are coupled with corresponding ports 31 (FIG. 2 ). Hose clamps150 help keep the hoses organized and prevent unwanted kinking. It isappreciated that any number of hose clamps 150 can be attached to rack148. During shipping or movement of container station 14, hose clamps150 can be removed so that they are not damaged and do not form anobstruction.

Accesses 104 and 114 (FIGS. 1 and 4 ) are in part provided so that whencontainer assembly 16 is being inserted within chamber 92, an operatorcan reach into chamber 92 through access 104 and/or 114 to helporientate and secure container assembly 16 within chamber 92 and to helpalign and/or feed various ports and tubes extends from containerassembly 16 with or through corresponding openings 110, 120, and thelike on support housing 78. In alternative embodiments, it isappreciated that door 106 can be used on both accesses 104 and 114 orthat door 116 can be used on both access 104 and 114. In otherembodiments, support housing 78 can be formed with only one of access104 or 114 or that both access 104 and 114 can be eliminated and opening110 and/or 120 can be formed directly on sidewall 82.

Returning to FIG. 4 , a plurality of radially spaced apart alignmentopenings 168 extend through sidewall 82 of support housing 78 at lowerend 86. A catch 170 laterally projects from an exterior surface ofsidewall 82 into alignment with each alignment opening 168. As containerassembly 16 is being inserted into chamber 92 of support housing 78,before it is filled with fluid, container 18 is spread apart andalignment tabs 38 (FIG. 2 ) of container assembly 16 are advancedthrough corresponding alignment openings 168 and secured to acorresponding catch 170. This positioning helps ensure that containerassembly 16 is properly positioned and spread apart so that container 18fully and properly expands during filling with fluid as opposed to partsof container 18 being kinked or remaining folded during filling. It isappreciated that catches 170 can have a variety of differentconfiguration and can also be in the form of straps, elastic cords orthe like that can engage and secure tabs 38 to container station 14.

As shown in FIG. 1 , support housing 78 can also comprise a handle 174attached to an outwardly extending sidewall 82. Handle 174 is shownhaving an elongated U-shaped configuration but can also have otherdesigns. A plurality of vertically aligned observation slot 176 extendalong the height of sidewall 82 and extend through sidewall 82 so as tocommunicate with chamber 92. Observation slots 176 permit and easyverification of the level of fluid within container 18.

Turning to FIG. 6 , floor 88 of support housing 78 has an enlargedcentral opening 176 into which a plate 178 is removably positioned.Plate 178 has a slot 180 that extends from a perimeter edge of plate 178toward a center of plate 178. As such, plate 178 has a generallyC-shaped configuration. Plate 178 typically freely sits on floor 88 andcan be removed by being pushed up into chamber 92. During use, ascontainer assembly 16 is lowered into chamber 92, a user can push plate178 out of opening 176 and reach up through opening 176 to grasp gasline 36. Gas line 36 is then pulled down through opening 176 and sparger34 (FIG. 2 ) is directed towards opening 176. Finally, gas line 36passes into slot 180 and plate 178 is fitted within opening 176 so thatsparger 34 rests on or is disposed adjacent to plate 178.

In one embodiment of the present invention means are provided forregulating the temperature of the fluid that is contained withincontainer 18 when container 18 is disposed within support housing 78. Byway of example and not by limitation, sidewall 82 can be jacketed so asto bound one or more fluid channels that encircle sidewall 82 and thatcommunicate with an inlet port 184 and an outlet port 186. A fluid, suchas water or propylene glycol, can be pumped into the fluid channelthrough inlet port 184. The fluid then flows in pattern around sidewall82 and then exits out through outlet port 184.

By heating or otherwise controlling the temperature of the fluid that ispassed into the fluid channel, the temperature of support housing 78 canbe regulated which in turn regulates the temperature of the fluid withincontainer 18 when container 18 is disposed within support housing 78. Inan alternative embodiment, electrical heating elements can be mounted onor within support housing 78. The heat from the heating elements istransferred either directly or indirectly to container 18.Alternatively, other conventional means can also be used such as byapplying gas burners to support housing 78 or pumping the fluid out ofcontainer 18, heating the fluid and then pumping the fluid back intocontainer 18. When using container 18 as part of a bioreactor orfermenter, the means for heating can be used to heat the culture withincontainer 18 to a temperature in a range between about 30° C. to about40° C. Other temperatures can also be used.

Returning to FIG. 4 , cart 80 comprises a platform 190 having a topsurface 192 and an opposing bottom surface 194. In the depictedembodiment, platform 190 has a substantially triangular configuration.In alternative embodiments, however, platform 190 can be square,rectangular, circular, or of other polygonal or irregularconfigurations. Downwardly projecting from bottom surface 194 are aplurality of spaced apart wheels 196. A plurality of spaced apart legs198 extend between floor 88 of support housing 78 and top surface 192 ofplatform 190. Legs 198 provide an open gap between support housing 78and platform 190 so as to enable access to plate 178 (FIG. 6 ) aspreviously discussed.

Attached to and downwardly projecting from platform 190 is a lockingcatch 200. As perhaps better depicted in FIG. 6 , locking catch 200comprises a vertically extending face plate 202 and a pair of arms 204Aand 204B project back from opposing sides of face plate 202 incomplementary diverging angles so as to extend in a generally V-shapedorientation. Arm 204A has a first flange 206A and an second flange 208Aorthogonally projecting from opposing upper and lower ends of arms 204Aso as to be disposed in substantially parallel planes. An engagement rod210A is secured to and extends between flanges 206A and 206B at a spacedapart location from arm 204A. Similarly, flanges 206B and 208B extendfrom opposing upper and lower ends of arm 204B and have an engagementrod 210B extending therebetween. The operation and function of lockingcatch 200 will be discussed below in greater detail with regard todocking station 12.

As depicted in FIG. 7 , docking station 12 comprises stand 218 whichincludes a base 220 having a frame assembly 222 upstanding therefrom anda plurality of wheels 224 downwardly projecting therefrom. Morespecifically, base 220 comprises a pair of spaced apart runners 266A and226B extending in parallel alignment. A first cross member 228 extendsbetween runners 266A and 266B at a rearward end thereof while a secondcross member 230 extends between runners 266A and 266B at a forward endthereof. A wheel 224 downwardly projects from each opposing end of eachrunner 266A and 266B. Frame assembly 222 comprises a plurality of spacedapart vertical risers 232 having a plurality of lateral supports 234extending therebetween. A horizontal platform 236 is mounted on frameassembly 222 forward of and at an elevation above first cross member228. A pair of spaced apart hand rails 238A and 238B extend fromcorresponding runner 226A and 226B and connect with frame assembly 222.

Mounted on second cross member 230 of base 220 is a locking assembly244. Locking assembly 244 comprises a housing 246 having a front face248. As depicted in FIG. 8 , front face 248 comprises an outwardlyflaring, substantially U-shaped receiver 250 having end faces 252A and252B extending from the opposing ends thereof. Access slots 254A and254B are formed on end faces 252A and 252B, respectively. Receiver 250bounds a recess 256 of complimentary shape that is configured to receiveface plate 202. Locking assembly 244 further comprises a pair ofengaging arms 258A and 258B. Each arm 258A and 258B has a first end 260disposed within housing 246 and an opposing second end 262 that projectsout through a corresponding access slot 254. Engaging arms 258A and 258Bhave a notch 264A and 264B, respectively, that are opposingly facing.

Engaging arms 258A and 258B can be movably positioned between a lockingposition as shown in FIG. 8 wherein second end 262 of arms 258 pivottowards each other and a release position wherein second end 262 ofengaging arms 258 are pivoted away from each other. A mechanicalassembly is used for moving engaging arms 258 between the two positions.The mechanical assembly includes an axel 266A secured to housing 246 andextending through first end 260 of engaging arm 258A so that engagingarm 258A can pivot about axel 266A. A pivot plate 268A is secured tofirst end 260 of engaging arm 258A so as to also pivot about axel 266A.A linkage 270A has a first end 272A pivotally mounted to pivot plate268A and an opposing second end 274A mounted to a guide pin 276. Guidepin 276 can pivot within and slide along a guide slot 278 that is formedon a bracket 280. Bracket 280 is secured to housing 246. A correspondingaxel 266B, pivot plate 268B, and linkage 270B are similarly coupled withengaging arm 258B. A lever 282 is pivotally mounted to housing 246 orbase 220 and includes a first end 284 coupled with guide pin 276 and anopposing second end 286 (FIG. 7 ). As a result of the mechanicallinkage, manual manipulation of second end 286 of lever 282 pivotsengaging arms 258A and 258B between the locking and release positions.Finally, locking assembly 244 also includes a spring 288 resilientlyextending between pivot plates 268A and 268B a location forward of axels266A and 266B. As a result of this configuration, spring 288 functionsto resiliently pivot second end 262 of engaging arms 258A and 258Btowards each other.

During use, it is desirable to engage locking assembly 244 with lockingcatch 200 so that container station 14 is rigidly locked with dockingstation 12. This is accomplished by advancing locking catch 200 intorecess 256 of locking assembly 244. Locking catch 200 has aconfiguration complimentary to and is configured to nest within recess256 so that the structures are self aligning as they couple together. Aslocking catch 200 advances into recess 256, engagement rods 210 strikeagainst the inside face of engagement arms 258A and 258B, respectively.Because of the inward sloping of the faces, engagement arms 258A and258B resiliently flex outward against the resistant spring 288 asengagement rods 210 are advanced forward.

Finally, once engagement rods 210 are advanced to notches 264A and 264B,engagement arms 258 resiliently pivot inward thereby retainingengagements rods 210A and 210B within notches 252A and 252B. In thisposition, container station 14 is rigidly secured to docking station 12.As discussed below in greater detail, in this position, docking station12 can be used to facilitate mixing and other processing of fluid withincontainer assembly 16. When it is desired to separate container station14 from docking station 12, lever 282 is moved so that engagement arms258 are spread apart into the release position thereby releasingengagement with locking catch 200. It is appreciated that there are avariety of different types of locking systems that can be used forremovably securing container station 14 to docking station 12.

Returning to FIG. 7 , docking station 12 further comprises a drive motorassembly 300 coupled with stand 218 by an adjustable arm assembly 302.Drive motor assembly 300 is used in conjunction with drive shaft 362(FIG. 3 ) and can be used for mixing and/or suspending a culture orother solution within container 18 (FIG. 2 ). Turning to FIG. 9 , drivemotor assembly 18 comprises a housing 304 having a top surface 306 andan opposing bottom surface 308. An opening 310 extends through housing304 from top surface 306 to bottom surface 308. A tubular motor mount312 is rotatably secured within opening 310 of housing 304. Upstandingfrom motor mount 312 is a locking pin 316. A drive motor 314 is mountedto housing 304 and engages with motor mount 312 so as to facilitateselect rotation of motor mount 312 relative to housing 304. Drive shaft362 is configured to pass through motor mount 312 so that engagingportion 372 of drive shaft 362 is retained within motor mount 312 andlocking pin 316 of motor mount 312 is received within notch 376 of driveshaft 362. As a result, rotation of motor mount 312 by drive motor 314facilitates rotation of drive shaft 362. Further discussion of drivemotor assembly 300 and how it engages with drive shaft 362 andalternative designs of drive motor assembly 300 are discussed in USPublication No. 2011/0188928 which was previously incorporated herein byspecific reference.

Arm assembly 302 is used to adjust the position of drive motor assembly300 and thereby also adjust the position of drive shaft 362. As depictedin FIG. 10 , arm assembly 302 comprises a first housing 318 that isrigidly secured to stand 218. Slidably disposed within first housing 318is an elongated first support 320. First housing 318 and first support320 are orientated such that first support 320 can slide vertically upand down along a first axis 322 (FIG. 11 ). In one embodiment, axis 322can extend orthogonally to a horizontal surface on which docking station12 is disposed. In alternative embodiments, first housing 318 and firstsupport 320 can be disposed so that axis 322 is disposed at an angle ina range between 0° to about 30° relative to a horizontal surface. Otherangles can also be used.

In one embodiment of the present invention, means are provided forselectively locking first support 320 to first housing 318 at differentlocations along axis 322. In one embodiment of the present invention,such means comprises holes 324 formed at spaced apart locations alongfirst support 320 and a spring activated pin 326 mounted to firsthousing 318. By pulling 326 out pin 326, first support 320 is free toslide vertically up and down along axis 322. By pushing the pin 326 in,pin 326 is received within a corresponding hole 324 so as to lock firstsupport 320 in place. It is appreciated that any number of conventionalclamps, pins, screws, latches, fasteners, or the like can be used forsecuring first support 320 to first housing 318. Indicia or markings 328can be formed along the surface of first support 320 to indicate therelative position of first support 320.

First support 320 terminates at an upper end 330. Mounted on upper end330 is a second housing 332. A second support 334 has a first end 352and an opposing second end 354. First end 352 is slidably mounted onsecond housing 332 so that second support 334 can be positioned atvarious locations along a second axis 335. Second support 334 and secondhousing 332 are typically disposed so that second axis 335 ishorizontally disposed and is orthogonal to first axis 322. Inalternative embodiments, however, second axis 335 can be disposed at anangle in a range between 0° to about 30° relative to first axis 322.Other angles can also be used.

Rails are typically disposed within second housing 332 on which secondsupport 334 slides. In alternative embodiments, a variety of alternativemechanism can be used to permit second support 334 to slide relative tosecond housing 332. In one embodiment of the present invention, meansare provided for selectively locking second support 334 at differentlocations along second housing 332. By way of example and not bylimitation, second housing 332 is shown having a top surface 336 havingan elongated slot 338 formed along the length thereof. A spring actuatedpin is disposed within slot 338 and extends through second support 334.A plurality of spaced apart holes are formed on the bottom surface ofsecond housing 332 or along the rails or other structures disposedwithin second house 332. During use, when pin 340 is elevated, secondsupport 334 is free to slide back and forth along second housing 332along second axis 335. When pin 340 is pressed down, pin 340 is receivedwithin a hole to thereby lock pin 340 and second support 334 in place.Indicia 342 can be disposed on top surface 336 to identify predefinedlocations for second support 344.

A third support 346 is rotatably mounted to second end 354 of secondsupport 334. Third support 346 is mounted so that it rotates about athird axis 348. Third axis 348 can be disposed in a horizontal plane andor in the same plane as second axis 335. Third axis can also be disposedat an angle in a range between about 0° to about 30° relative to secondaxis 335. Drive motor assembly 300 is secured to third support 346 suchthat rotation of third support 346 facilitates concurrent rotation ofdrive motor assembly 300.

One embodiment of the present invention also includes means for lockingthird support 346 at different angles about third axis 348. By way ofexample and not by limitation, a spring activated pin 350 is mounted onthird support 346. When pin 350 is retracted, third support 346 is freeto rotate about third axis 348. As pin 350 is advanced inward, it isreceived within one of a plurality of holes formed on second end 354 ofsecond support 334. As a result, third support 346 is thereby precludedfrom further rotation. Other conventional fastening techniques can alsobe used.

In view of the foregoing, first support 320 can facilitate verticalmovement of drive motor assembly 300, second support 334 can facilitatehorizontal movement of drive motor assembly 300 and third support 346can facilitate rotational movement of drive motor assembly 300. As aresult, arm assembly 302 can be used to position drive motor assembly300 and drive shaft 362 which extends there through in a variety ofdifferent locations and orientations. As a result, arm assembly 302enables docking system station 12 to be used with a variety of differentsized and shaped container stations 14.

During use, container station 14 is wheeled to docking station 12 and/ordocking station 12 is wheeled to container station 14 and the two aresecurely coupled together, as shown in FIG. 1 , by engaging lockingassembly 244 (FIG. 7 ) with catch 200 (FIG. 4 ). In this secureposition, arm assembly 302 is used to properly position drive motorassembly 300 so that rotational assembly 48 (FIG. 2 ) can be coupledwith drive motor assembly 300. Specifically, as depicted in FIG. 12 ,housing 304 of drive motor assembly 300 has an open access 384 that isrecessed on a front face 386 so as to communicate with opening 310extending through housing 304. Access 384 is in part bounded by asubstantially C-shaped first side wall 388 that extends up from bottomsurface 308, a concentrically disposed substantially C-shaped secondside wall 390 disposed above first side wall 388 and having a diameterlarger than first side wall 388, and a substantially C-shaped shoulder392 extending between side walls 388 and 390. As shown in FIG. 2 , adoor 394 is hingedly mounted to housing 304 and selectively closes theopening to access 384 from front face 386. Returning to FIG. 12 , door394 is secured in a closed position by a latch 396. Positioned on firstside wall 388 is a section 398 of a resilient and/or elastomericmaterial such as silicone. Other sections 398 of similar materials canalso be positioned on first side wall 388 or the interior surface ofdoor 394.

As depicted in FIG. 13 , to facilitate attachment of rotational assembly48 to housing 304, with door 394 rotated to an open position, rotationalassembly 48 is horizontally slid into access 384 from front face 386 ofhousing 304 so that a support flange 400 radially outwardly extendingfrom an upper end of rotational assembly 48 rests on shoulder 392 ofaccess 384. Rotational assembly 48 is advanced into access 384 so thatthe passage extending through hub 54 of rotational assembly 48 alignswith the passage extending through motor mount 312 (FIG. 9 ). In thisposition, door 394 is moved to the closed position and secured in theclosed position by latch 396. As door 394 is closed, casing 50 ofrotational assembly 48 is biased against the one or more sections 398(FIG. 12 ) of resilient material so as to clamp rotational assembly 48within access 384 and thereby prevent unwanted rotational movement ofcasing 50 relative to housing 304 of drive motor assembly 300.

Once rotational assembly 48 is secured to drive motor assembly 300,drive shaft 362 can be advanced down through drive motor assembly 300and into impeller assembly 40 so as to engage impeller 64. Once driveshaft 362 is properly positioned, drive motor assembly 300 is activatedcausing drive shaft 362 to rotate impeller 64 and thereby mix or suspendthe fluid within container 18. When the processing is complete, driveshaft 362 is removed and rotational assembly 48 is separated from drivemotor assembly 300. Container station 14 can then be separated fromdocking station 12 by releasing catch 200 from locking assembly 244. Asecond container station 14 can then be couple with docking station 12in the same manner as discussed above. Where the second containerstation 14 is a different size or configuration or where the containerassembly 16 coupled thereto is a different size or configuration, armassembly 302 can be used to properly position drive motor assembly 300at a potentially different location so that the new rotational assembly48 can be coupled with drive motor assembly 300. Drive shaft 362 canthen again be advanced down through drive motor assembly 300 and intoimpeller assembly of the new container assembly 16.

In view of the foregoing, it is appreciated that a single dockingstation 14 can be used with a variety of different container stations 14and/or container assemblies 16 wherein the different container stations14 and/or container assemblies 16 can be of different size and/or shape.

Depicted in FIG. 14 is an alternative embodiment of the presentinvention. In this embodiment drive motor assembly 300 operates with acontainer 404 that is an open top liner. Container 404 is positionedwithin chamber 92 of support housing 78 so that is drapes over annularlip 94 (FIG. 1 ). This configuration can be used as a lower costalternative for mixing non-sterile fluids. In this embodiment,rotational assembly 48 merely functions to secure impeller assembly 40to drive motor assembly 300 so that it does not unintentionally slideoff of drive shaft 362. In alternative embodiments, because rotationalassembly 48 is no longer forming a sealed fluid connection with thecontainer, rotational assembly 48 can be substantially simplified. Forexample, as shown in FIG. 15 , rotational assembly 48 can be replaced bya clamp 406 that secures tubular connector 42 to drive shaft 362.Further alternative embodiments with regard to impeller assembly 40 andhow they can be attached to drive motor assembly 300 or drive shaft 362are discussed in US Publication No. 2011/0188928 which was previouslyincorporated herein by specific reference.

Depicted in FIG. 16 is an alternative embodiment of an inventive mixingsystem incorporating features of the present invention. Like elementsbetween systems 10 and are identified by like reference characters. Ingeneral, mixing system 10A comprises docking station 12, a containerstation 14A that removably docks with docking station 12, a containerassembly 16A that is supported within container station 14A, and driveshaft 362 (FIG. 3 ) that extends between docking station 12 andcontainer assembly 16A.

As depicted in FIG. 17 , container assembly 16A comprises container 18having impeller assembly 40 attached thereto the same as in containerassembly 16. However, in contrast to container assembly 16 which wasdesigned to function as part of a fermentor or bioreactor, containerassembly 16A is primarily designed for mixing and transporting fluids.As such, sparger 34 of container assembly 16 has been removed andreplaced with a port 410 centrally secured on a floor 411 of container18. A drain line 412, which is typically in the form of a flexible tube,is coupled to and extends from port 410. A hose clamp 413, as is knownin the art, can be attached to drain line 412 for controlling the flowof fluid therethrough.

Container assembly 16A also comprises a plurality of radially spacedapart alignment tabs 414 projecting from upper end 22 of container 18.In the embodiment depicted, each alignment tab 414 comprises a singletab welded to container 18 and having a opening 415 extendingtherethrough. In alternative embodiments, alignment tabs 414 cancomprise a loop of material that bound an opening passing therethroughor can have other configurations that permit the tab to attach to astructure. As will be discussed below in greater detail, tabs 414 can beused for proper positioning and supporting container assembly 16A withincontainer station 14A. Fluid lines 416 are shown connected to ports 30at upper end 22 and can also be used in container assembly 16. It isappreciated that container assembly 16A can have the same components, bemade of the same materials, have the same sizes and shapes, and have allother alternatives as previously discussed above with regard tocontainer assembly 16. However, because container assembly 16 iscommonly used for transporting fluids, container assembly 16A typicallyhas a volume in a range between about 10 liters to about 250 liters withabout 25 liters to about 150 liters being more common. Other volumes canalso be used.

Turning to FIG. 18 , container stations 14A generally comprises ashipping vessel 420 removably mounted on a cart 422. Cart 422 comprisesa platform 424 having a top surface 426 and an opposing bottom surface428. In the depicted embodiment, platform 424 has a substantially squareconfiguration. In alternative embodiments, however, platform 424 can betriangular, rectangular, circular, or of other polygonal or irregularconfigurations. Downwardly projecting from bottom surface 428 are aplurality of space apart wheels 430 which can be pivotally mounted toplatform 424. Also downwardly projecting from bottom surface 428 orotherwise attached to platform 424 is locking catch 200 which waspreviously discussed with regard to FIG. 6 . Locking catch 200 ismounted to cart 422 so that cart 422 can couple with docking station 12in the same way that container station 14 can couple with dockingstation 12 as previously discussed with regard to FIGS. 7 and 8 .

As depicted in FIG. 19 , cart 422 further comprises a support base 432and a plurality of spaced apart legs 434 that extend between platform424 and support base 432. In the embodiment depicted, support base 432is shown as comprising a pair of crossed beams 433A and B but inalternative embodiments can comprise a plate or any other structure thatcan support shipping vessel 420. Mounted on and encircling support base432 is an annular retaining wall 436. Retaining wall 436 has an insideface 437 that extends from a bottom edge 439 to an opposing top edge441. A recess 443 is formed on top edge 441. Inside face 437 bounds acavity 438 extending above support base 432 into which shipping vessel420 is received. Retaining wall 436 thus helps to prevent shippingvessel 420 from laterally sliding off of support base 432. Inalternative embodiments, it is appreciated that retaining wall 436 neednot comprise a continuous encircling structure but can comprise aplurality of spaced apart posts or spaced apart sections of the depictedretaining wall 436. In yet another alternative, retaining wall 436 canhave a substantially C-shaped configuration.

Turning to FIG. 20 , cart 422 further comprises a pair of foldablehandles 440A and 440B. Handle 440A comprises a first handle portion 442having a substantially L-shape configuration that extends out from oneof legs 434 and terminates at a vertical riser 444. Vertical riser hasan inverted T-shaped slot 456 that extends down from a top edge thereof.Handle 440A also comprises a second handle portion 448 that includes apost 450 slidably received within vertical riser 444, an extension arm452 orthogonally projecting from post 450, and a hand grip 454orthogonally projecting from extension arm 452. A pin 446 radiallyoutwardly projects from post 450 and is slid down the vertical sectionof slot 456 so as to be received within the horizontal section of slot456. Slot 456 forms a path along which pin 446 can travel so that secondhandle portion 448 can rotate laterally over a defined distance or beremoved from first handle portion 442 so that second handle portion 448is not obstructive. Handle 440B has the same configuration as handle440A and thus functions in a similar manner.

As also shown in FIG. 20 , shipping vessel 420 comprises an annular sidewall 470 having an interior surface 472 and an opposing exterior surface474 that longitudinally extend between an upper end 476 and opposinglower end 478. Interior surface 472 bounds a chamber 480. An annular lip482 formed at upper end 476 bounds an access opening to chamber 480.

Turning to FIG. 21 , although not required, in one embodiment, a basefloor 484 is formed at bottom end 474 of side wall 470. In oneembodiment, base floor 484 and side wall 470 combine to form a barrelhaving a cylindrical configuration. However, in alternative embodiments,side wall 470 need to be cylindrical but can have a square, polygonal,irregular, or any other desired cross sectional configuration. An accessport 490 extends through side wall 470 at lower end 478. An annularsleeve 492 is disposed on side wall 470, such as by adhesive, thermalwelding, integral molding, or the like, and projects into chamber 480.Sleeve 492 has an interior surface 494 which can be threaded. In turn, aplug 496 can have a threaded surface 498 such that plug 496 can bethreaded into sleeve 492 for selectively closing access port 490. Apolygonal post 499 or corresponding socket can be formed on plug 496 toenable plug 496 to be rotated by a tool. In alternative embodiments,plug 496 can be secured within access port 490 through a frictionconnection, bayonet connection, or any other type of conventionalremovable connection.

Positioned within chamber 480 is a floor insert 500. Floor insert 500comprises an annular support wall 502 extending from a first end 504 toan opposing second end 506. A recess 508 is formed on second end 506 ofsupport wall 502. Support wall 502 is configured to be freely passeddown through chamber 480 until second end 506 rests on base floor 484with sleeve 492 being received within recess 508. Floor insert 500further comprises a support floor 510 that has a substantiallyfrustoconical configuration. More specifically, support floor 510 has aninterior surface 512 and an opposing exterior surface 514 that slopedownwardly and radially inward from a first end 516 connected to firstend 504 of support wall 502 to an opposing second end 518. Second end518 bounds an annular opening 520. A plurality of support braces 522extend between support wall 502 and support floor 510. As a result ofsupport floor 510, chamber 480 is divided into an upper chamber 524 thatextends from annular lip 482 to support floor 510 and a lower chamber526 that extends from support floor 510 to base floor 484.

In one embodiment, floor insert 500 is removably positioned withinchamber 480 so that it is supported on base floor 484. In an alternativeembodiment, floor insert 500 can be secured within chamber 480 such asby welding, adhesive, or mechanical connection. In yet other alternativeembodiments, support wall 502 can be eliminated and support floor 510can be welded or otherwise secured directly to interior surface 472 ofside wall 470. Another alternative design for shipping vessel 420 isdisclosed in U.S. Pat. No. 7,153,021, which is incorporated herein byspecific reference. Shipping vessel 420 is typically comprised ofplastic but can be made of metal, composite, or other desired materials.

Returning back to FIG. 20 , a retention ring 540 is used for securingcontainer assembly 16A within upper chamber 524 of shipping vessel 420.Retention ring 540 comprises a substantially C-shaped ring body 542 thatterminates at opposing ends having flanges 544A and 544B formed thereat.A fastener 546 extends through flanges 544A and B and can be used forselectively drawing and securing flanges 544A and B together. In oneembodiment, fastener 546 can comprise a blot and nut assembly. Inalternative embodiments, fastener 546 can comprise a clamp, latch, orany other conventional fastener that achieve the desired objective.

Ring body 542 is typically in the form of a narrow band having an insideface 548 and an opposing outside face 550. A plurality of spaced apartcatches 552 are mounted on inside face 548 of ring body 542. In oneembodiment, each catch 552 comprises a elongated pin having a first end554 that is secured, such as by welding, at a central location on insideface 548. Each pin also comprises an opposing second end 556 thatprojects up above ring body 540. If desired, second end 556 of each pincan be rounded. Although not required, in one embodiment a plurality ofspaced apart notches 558 are recessed on the bottom edge of ring body542 such that the top of each notch 558 is disposed adjacent to firstend 554 of a corresponding catch 552.

During use, fastener 546 is loosened so as to expand the size of ringbody 542. Ring body 542 is then positioned on upper end 476 of shippingvessel 420 so that ring body 542 encircles exterior surface 474 of sidewall 470. In this configuration, first end 554 of each catch 552 restson top of annular lip 482 of side wall 470 so that retention ring 540 isproperly positioned. If desired, a flange can be formed at first end 554of each catch 552 for receiving annular lip 482. Notches 558 permit avisual inspection to ensure that ring body 542 is properly seated.Fastener 546 is then used to clamp retention ring 540 on side wall 470.As container assembly 16A (FIG. 17 ) is inserted within upper chamber524, second end 556 of each catch 552 is passed through opening 415 of acorresponding alignment tab 414 so that container assembly 16A issupported and suspended within upper chamber 542 as shown in FIG. 16 .

As shown in FIG. 22 , during use shipping vessel 420 is manuallypositioned on cart 422 so that lower end 478 is received withinretaining wall 436. Shipping vessel 420 is oriented so that access port490 on shipping vessel 420 is aligned with recess 443 on retaining wall436. Either before or after removably positioning shipping vessel 420 oncart 422, retention ring 540 is removably secured to upper end 476 ofshipping vessel 420 as discussed above. An empty container assembly 16A(FIG. 17 ) is then position within upper chamber 524 of shipping vessel420 so that catches 552 pass through openings 415 in alignment tabs 414(FIG. 16 ).

Plug 496 can then be removed and an operator can reach through accessport 490 and guide drain line 412 (FIG. 17 ) down through opening 520 ofshipping vessel 420 (FIG. 21 ) and into lower chamber 526 where drainline 412 is temporarily stored. Port 410 of container assembly 16A (FIG.17 ) can also be pulled down and positioned at or adjacent to opening520 of shipping vessel 420 so that container assembly 16A is properlypositioned within upper chamber 524 of shipping vessel 420. If desired,plug 496 can be then reinserted. In alternative embodiments, it isappreciated that retention ring 540 is not required. In this embodiment,container assembly 16A is unfolded and freely positioned within upperchamber 524 of shipping vessel 420. As container assembly 16A is filledwith fluid, additional care must be taken to adjust container assembly16A so that it remains properly positioned and is not kinked or folded.

Next, cart 422 is coupled with docking station 12 as depicted in FIG. 16. This is accomplished by locking catch 200 (FIG. 18 ) on cart 422coupling with locking assembly 244 (FIG. 7 ) on docking station 12 inthe same way that container assembly 14 couples with docking station 12as previously discussed. It is appreciated that docking station 12and/or cart 14 can be moved as part of this docking process. Oncedocking station 12 and cart 422 are securely coupled together,rotational assembly 48 (FIG. 17 ) of container assembly 16A is coupledwith drive motor assembly 300 as previously discussed and shown in FIG.16 . Depending on the size of container station 14A, it may be necessaryto adjust the vertical height or orientation of drive motor assembly 300as previously discussed.

Next, drive shaft 362 (FIG. 3 ) is advanced down through drive motorassembly 300 and into impeller assembly 40 as also previously discussed.Depending on the size of Either prior to or after the insertion of driveshaft 362, fluid is delivered into compartment 28 of container assembly16A through one of fluid lines 416 (FIG. 17 ). Drive motor assembly 300can then be activated to mix the components within container assembly16A. Once the desired processing is complete, drive shaft 362 can beremoved and cart 422 separated from docking station 12. Becausecontainer assembly 16A now contains fluid and is fully supported by sidewall 470 and support floor 510 of shipping vessel 420 (FIG. 21 ), theretention ring 540 can be removed from shipping vessel 420 and containerassembly 16A. Fluid lines 416 can be coiled and placed on top ofcontainer 18 within upper chamber 524. A lid 564, as shown in FIG. 23 ,can then be removably secured to upper end 476 of shipping vessel 420 soas to close off the opening thereof. If desired, lid 564 can be securedto shipping vessel 420 by fasteners, straps, clamps, or the like.

With lid 564 secured, shipping vessel 420 can be removed from cart 422.Shipping vessel 420, containing container assembly 16A with fluidtherein, is then often moved to a temporary storage room. Where thefluid is media or other fluid that should be refrigerated, the storageroom can be a cold room. When needed, shipping vessel 420 can beshipped, such as through a truck, train, airplane, ship or the like, toa customer, related facility, end user, or any other desireddestination. Again, where needed, the shipping vehicle can have arefrigerated compartment for carrying shipping vessel 420. Inalternative embodiments, it is appreciated that shipping vessel 420 canremain on cart 422 and the entirely assembly can be stored and/orshipped. Once shipping vessel 420 reaches the desired destination, it isthen placed on a second cart 422 located at the destination which secondcart 422 is then coupled with a second docking station 12 located at thedestination. Either before or after coupling with second docking station12, lid 564 is removed. Rotational assembly 48 is then coupled withdrive motor assembly 300 and drive shaft 362 is coupled therewith aspreviously discussed with regard to FIG. 16 . If needed, the height ororientation of drive motor assembly 300 can be adjusted. Drive motorassembly 300 can then be activated to mix or resuspend fluids containedwith container assembly 16A. Further processing of the fluid withincontainer assembly 16A, such as adding additional components, can thenalso occur. Either while coupled with the second docking station 12 orafter being removed therefrom, plug 496 can be removed and drain line412 (FIG. 17 ) passed out through access port 490 (FIG. 21 ) and coupledwith a further container or fluid line for transferring the fluid out ofcontainer assembly 16A. Once the fluid has been used, the containerassembly 16A can be disposed of and shipping vessel 420 returned to theoriginal location for reuse with a new container assembly 16A.

It is appreciated that the inventive system provides a modular systemwherein standardized components, such as docking station 12 and cart422, can be located at a number of different locations. Shipping vessel420 can then be easily transported between the different locations andthe fluid therein mixed or resuspended along with other processingwithout having to transfer the fluid to different containers. This helpsto ensure sterility while minimizing costs and effort in performing thedesired processing. The inventive system and method also permits reuseof shipping vessel 420 and disposal of container assembly 16 without therequirement for any washing or sterilization.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

1.-17. (canceled)
 18. A fluid mixing system (10) comprising: (i) a cart(80) comprising: a frame (190); and a plurality of wheels (196) mountedto the frame; (ii) a docking station (12) comprising: a stand (218); alocking assembly (244) secured to the stand, the locking assemblycoupled to the cart so that the cart is releasably secured to thedocking station; a drive motor assembly (300) mounted to the stand; and(iii) a container station (14) supported on the cart, the containerstation comprising: a collapsible bag (18) bounding a compartment, thecollapsible bag being at least partially received within the containerstation; and (iv) an elongated drive shaft (362) removably coupled withthe drive motor assembly by an adjustable arm assembly (302) andremovably coupled with a mixing element (64) located within thecompartment of the collapsible bag, the drive motor assembly beingconfigured to rotate the drive shaft.
 19. The mixing system of claim 18,wherein the arm assembly is configured to adjust a position of the drivemotor assembly and thereby adjust a position of the drive shaft.
 20. Themixing system of claim 18, wherein the arm assembly comprises a firsthousing having a first support, and the first housing being rigidlysecured to the stand.
 21. The mixing system of claim 20, wherein thefirst housing and the first support are orientated such that the firstsupport can slide vertically up and down along a first axis.
 22. Themixing system of claim 20, wherein the first axis can extendorthogonally to a horizontal surface on which the docking station isdisposed.
 23. The mixing system of claim 22, wherein the first housingand first support are disposed so that the first axis is disposed at anangle in a range between 0° to about 30° relative to the horizontalsurface.
 24. The mixing system of claim 22, wherein the first support isconfigured to selectively lock the first housing at different locationsalong the first axis.
 25. The mixing system of claim 22, wherein thefirst support comprises a plurality of holes at spaced apart locationsand a spring-activated pin mounted to the first housing.
 26. The mixingsystem of claim 25, wherein the first support is configured to beslidable along the first axis when the pin is pulled out of acorresponding hole in the first support.
 27. The mixing system of claim23, wherein the first support is configured to be locked in place whenthe pin is received in a corresponding hole in the first support. 28.The mixing system of claim 20, wherein the arm assembly furthercomprises a second housing having a second support, and the secondhousing being rigidly secured to the first support.
 29. The mixingsystem of claim 28, wherein the second housing and the second supportare orientated such that the second support can slide vertically up anddown along a second axis.
 30. The mixing system of claim 29, wherein thesecond axis is orthogonal to the first axis.
 31. The mixing system ofclaim 28, wherein the arm assembly further comprises a third supportrotatably mounted to the second support.
 32. The mixing system of claim31, wherein the third support is configured to rotate around a thirdaxis, the third axis being disposed in a horizontal plane and or in asame plane as the second axis.